Cleared Special

K060283 - TRANSET SYSTEM
(FDA 510(k) Clearance)

K060283 · Bonutti Research, Inc. · Orthopedic

Feb 2006

Decision

19d

Days

Class 2

Risk

K060283 is an FDA 510(k) clearance for the TRANSET SYSTEM, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on February 22, 2006, 19 days after receiving the submission on February 3, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K060283 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2006
Decision Date	February 22, 2006
Days to Decision	19 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF